Method and apparatus for fixing a graft in a bone tunnel

ABSTRACT

A method and apparatus for fixing a ligament in a bone tunnel by cross-pinning the ligament in the bone tunnel.

REFERENCE TO PENDING PRIOR PATENT APPLICATION

This patent application claims benefit of pending prior U.S. ProvisionalPatent Application Ser. No. 60/275,431, filed Mar. 13, 2001 by GregoryWhittaker for METHOD AND APPARATUS FOR FIXING A GRAFT IN A TIBIAL TUNNEL(Attorney's Docket No. MIT-ZZ PROV), which patent application is herebyincorporated herein by reference.

FIELD OF THE INVENTION

This invention relates to surgical methods and apparatus in general, andmore particularly to methods and apparatus for fixing a graft in a bonetunnel.

BACKGROUND OF THE INVENTION

The complete or partial detachment of ligaments, tendons and/or othersoft tissues from their associated bones within the body are relativelycommonplace injuries. Tissue detachment may occur as the result of anaccident such as a fall, overexertion during a work-related activity,during the course of an athletic event, or in any one of many othersituations and/or activities. Such injuries are generally the result ofexcess stress being placed on the tissues.

In the case of a partial detachment, commonly referred to under thegeneral term “sprain”, the injury frequently heals itself, if givensufficient time and if care is taken not to expose the injury to unduestress during the healing process. If, however, the ligament or tendonis completely detached from its associated bone or bones, or if it issevered as the result of a traumatic injury, partial or permanentdisability may result. Fortunately, a number of surgical proceduresexist for re-attaching such detached tissues and/or completely replacingseverely damaged tissues.

One such procedure involves the re-attachment of the detached tissueusing “traditional” attachment devices such as staples, sutures and/orcancellous bone screws. Such traditional attachment devices have alsobeen used to attach tendon or ligament grafts (often formed fromautogenous tissue harvested from elsewhere in the body) to the desiredbone or bones.

Another procedure is described in U.S. Pat. No. 4,950,270, issued Aug.21, 1990 to Jerald A. Bowman et al. In this procedure, a damagedanterior cruciate ligament (“ACL”) in a human knee is replaced by firstforming bone tunnels through the tibia and femur at the points of normalattachment of the anterior cruciate ligament. Next, a graft ligament,with a bone block on one of its ends, is sized so as to fit within thebone tunnels. Suture is then attached to the bone block, and the sutureis thereafter passed through the tibial tunnel and then the femoraltunnel. The bone block is then drawn up through the tibial tunnel and upinto the femoral tunnel using the suture. As this is done, the graftligament extends back out the femoral tunnel, across the interior of theknee joint, and then out through the tibial tunnel. The free end of thegraft ligament resides outside the tibia, at the anterior side of thetibia. Next, a bone screw is inserted between the bone block and thewall of femoral bone tunnel so as to securely lock the bone block inposition by a tight interference fit. Finally, the free end of the graftligament is securely attached to the tibia.

In U.S. Pat. No. 5,147,362, issued Sep. 15, 1992 to E. Marlowe Goble,there is disclosed a procedure wherein aligned femoral and tibialtunnels are formed in a human knee. A bone block, with a graft ligamentattached thereto, is passed through the tibial and femoral tunnels to ablind end of the femoral tunnel, where the block is fixed in place by ananchor. The graft ligament extends out the tibial tunnel, and theproximal end thereof is attached to the tibial cortex by staples or thelike. Alternatively, the proximal end of the ligament may be fixed inthe tibial tunnel by an anchor or by an interference screw.

Various types of ligament and/or suture anchors, and anchors forattaching other objects to bone, are also well known in the art. Anumber of these devices are described in detail in U.S. Pat. Nos.4,898,156; 4,899,743; 4,968,315; 5,356,413; and 5,372,599.

One known method for anchoring bone blocks in bone tunnels is through“cross-pinning”, in which a pin, screw or rod is driven into the bone,transversely to the bone tunnel, so as to intersect the bone block andthereby “cross-pin” the bone block in the bone tunnel.

In this respect it should be appreciated that the cross-pin (i.e., theaforementioned pin, screw or rod) is generally placed in a pre-drilledtransverse passageway. In order to provide for proper cross-pinning ofthe bone block in the bone tunnel, a drill guide is generally used. Thedrill guide serves to ensure that the transverse passageway ispositioned in the bone so that the transverse passageway intersects theappropriate tunnel section and hence the bone block. Drill guides foruse in effecting such transverse drilling are shown in U.S. Pat. Nos.4,901,711; 4,985,032; 5,152,764; 5,350,380; and 5,431,651.

Other patents in which cross-pinning is discussed include U.S. Pat. Nos.3,973,277; 5,004,474; 5,067,962; 5,266,075; 5,356,435; 5,376,119;5,393,302; and 5,397,356.

Cross-pinning methods and apparatus currently exist for fixing a graftligament in a femoral bone tunnel. However, the femoral cross-pinningmethods and apparatus that are presently known in the art do not addressthe use of a cross-pin in a tibial bone tunnel, which involves adifferent set of considerations. Among these considerations areanatomical geometries, bone configurations, bone quality, etc.

Accordingly, there exists a need for a method and apparatus forpositioning at least one cross-pin so as to fix a graft in a tibial bonetunnel.

There also exists a need for a method and apparatus for positioning atleast one cross-pin across a tibial tunnel such that, upon completion ofthe procedure, the cross-pin is located in the cortical portion of thetibia, adjacent to the tibial plateau.

SUMMARY OF THE INVENTION

One object of the present invention is, therefore, to provide a novelmethod and apparatus for positioning at least one cross-pin so as to fixa graft in a tibial bone tunnel.

Another object of the present invention is to provide a novel method andapparatus for positioning at least one cross-pin across a tibial tunnelsuch that, upon completion of the procedure, the cross-pin is located inthe tibia and, more preferably, in the cortical portion of the tibia,adjacent to the tibial plateau.

These and other objects of the present invention are addressed by theprovision and use of a novel method and apparatus for fixing a graft ina bone tunnel.

In accordance with a feature of the present invention, there is providedapparatus for positioning at least one cross-pin in a bone through abone tunnel, the apparatus comprising: a bone tunnel guide rod having aproximal end and a distal end; a movable element slidably positionedabout the bone tunnel guide rod, wherein said movable element islockable into a position to selectively adjust the length of said guiderod between said distal end and said movable element; a frame memberhaving a base portion and an arm portion, the base portion attachable tothe proximal end of the bone tunnel guide rod; a drill guide memberattachable to the arm portion of the frame member; and drilling meansfor drilling at least one cross-pin hole in the bone and across the bonetunnel, with the drilling means being supported in position by the drillguide member, the drill guide member being in attachment with the framemember, the frame member being in attachment with the bone tunnel guiderod, and the bone tunnel guide rod being inserted into the bone tunnel,and the apparatus being held against the bone, with the movable elementlimiting further insertion into the bone tunnel.

In accordance with a further feature of the present invention, there isprovided a method for fixing a ligament in a bone tunnel, the methodcomprising the steps of: forming a bone tunnel in a bone, the bonetunnel comprising a first open end and a second open end, with a portionbetween the first open end and the second open end having a diametersized to receive the ligament; inserting a guide rod into the bonetunnel, the guide rod having a proximal end and a distal end;positioning the distal end of the guide rod adjacent to the second openend of the bone tunnel; positioning a movable element on the guide rodagainst the bone at the first open end of the bone tunnel; drilling atleast one cross-pin hole transversely through the bone and across thebone tunnel, using drilling means for drilling the cross-pin hole, thedrilling means being supported in position by a drill guide member, withthat drill guide member being in attachment with a frame member, theframe member being in attachment with the bone tunnel guide rod, thebone tunnel guide rod being inserted into the bone tunnel, and with themovable element limiting further insertion of the bone tunnel guide rodinto the bone tunnel; and inserting at least one cross-pin through atleast one cross-pin hole.

In accordance with a further feature of the present invention, there isprovided an apparatus for positioning at least one cross-pin in a bonethrough a bone tunnel, the apparatus comprising: a bone tunnel guide rodhaving a proximal end and a distal end, with the bone tunnel guide rodhaving a gradiated index between the proximal end and the distal end,wherein the gradiated index is read at a given position in the bonetunnel in relation to an intended position of at least one cross-pinhole; a frame member having a base portion and an arm portion, the baseportion attachable adjacent to the proximal end of the bone tunnel guiderod, and the arm portion of the frame member having a scalecorresponding with the gradiated index of the bone tunnel guide rod; adrill guide member attachable to the arm portion of the frame member,the drill guide member being selectively adjustable relative to thescale of the frame member; and drilling means for drilling the at leastone cross-pin hole in the bone through the bone tunnel, the drillingmeans being supported in position by the drill guide member, the drillguide member being in attachment with the frame member, and the framemember being in attachment with the bone tunnel guide rod, with the bonetunnel guide rod being inserted into the bone tunnel, with the distalend of apparatus being held against a terminal end of the bone tunnel,limiting further insertion into the bone tunnel.

In accordance with a further feature of the present invention, there isprovided a method for fixing a ligament in a bone tunnel, the methodcomprising the steps of: forming a bone tunnel in a bone, the bonetunnel comprising a first portion and a second portion, the firstportion having a first open end and a second open end, and the secondportion having a third open end and a fourth terminal end, and a portionbetween the first open end and the fourth terminal end having a diametersized to receive the ligament; inserting a bone tunnel guide rod intothe bone tunnel, the bone tunnel guide rod having a proximal end and adistal end, and the bone tunnel guide rod having a gradiated indexbetween the proximal end and the distal end; positioning the distal endof the guide rod against the fourth terminal end of the bone tunnel;determining the position of the gradiated index relative to the secondopen end of the bone tunnel; positioning a drill guide attached to aframe member, the frame member including a scale corresponding with thegradiated index of the bone tunnel guide rod, the drill guide beingpositioned relative to the scale in accordance with the gradiated indexrelative to the second open end of the bone tunnel; drilling at leastone cross-pin hole transversely through the bone into the bone tunnelusing drilling means for drilling the cross-pin hole, the drilling meanssupported in position by the drill guide member, the drill guide memberbeing in attachment with the frame member, the frame member being inattachment with the bone tunnel guide rod, the bone tunnel guide rodbeing inserted into the bone tunnel, and the fourth terminal end of thebone tunnel limiting further insertion into the bone tunnel; andinserting at least one cross-pin through the cross-pin hole.

In accordance with a further feature of the present invention, there isprovided an apparatus for positioning at least one cross-pin in a bonethrough a bone tunnel, the apparatus comprising: a kit of bone tunnelguide rods, each of the bone tunnel guide rods including a proximal endand a distal end, and each of the bone tunnel guide rods includinginsertion limiting means for limiting insertion into the bone tunnel,the insertion limiting means of each of the bone tunnel guide rods beinglocated a given distance from its distal end, the kit including at leasttwo bone tunnel guide rods, with the given distance of each of the bonetunnel guide rods being different from one another, and whereinselection from the kit is made by inserting at least one of the bonetunnel guide rods into the bone tunnel and selecting a bone tunnel guiderod that has its distal end aligned with a bone surface when saidinsertion limiting means is in engagement with another bone surface; aframe member having a base portion and an arm portion, the base portionattachable adjacent to the proximal end of the selected bone tunnelguide rod; a drill guide member attached to the arm portion of the framemember; drilling means for drilling the at least one cross-pin hole inthe bone through the bone tunnel, the drilling means being supported inposition by the drill guide member, the drill guide member being inattachment with the frame member, and the frame member being inattachment with the selected bone tunnel guide rod, with the selectedbone tunnel guide rod being inserted into the bone tunnel, and with theinsertion limiting means preventing further insertion into the bonetunnel.

In accordance with a further feature of the present invention, there isprovided a method for fixing a ligament in a bone tunnel, the methodcomprising the steps of: forming a bone tunnel in a bone, the bonetunnel comprising a first open end and a second open end, with a portionbetween the first open end and the second open end having a diametersized to receive the ligament; inserting at least one guide rod from akit of bone tunnel guide rods into the bone tunnel, each of the bonetunnel guide rods including a proximal end and a distal end, and each ofthe bone tunnel guide rods including insertion limiting means forlimiting insertion into the bone tunnel, the insertion limiting means ofeach of the bone tunnel guide rods being located a given distance fromits distal end, the kit including at least two bone tunnel guide rods,with the given distance of each of the bone tunnel guide rods beingdifferent from one another; inserting at least one of the bone tunnelguide rods into the bone tunnel and selecting a bone tunnel guide rodthat has its distal end aligned with the second end of the bone tunnelwhen the insertion limiting means is in engagement with the boneadjacent the first end of the bone tunnel; drilling at least onecross-pin hole transversely through the bone and across the bone tunnel,using drilling means for drilling the cross-pin hole, the drilling meansbeing supported in position by a drill guide member, with the drillguide member being in attachment with a frame member, the frame memberbeing in attachment with the selected bone tunnel guide rod, theselected bone tunnel guide rod being inserted into the bone tunnel, andwith the insertion limiting means limiting further insertion of the bonetunnel guide rod into the bone tunnel; and inserting at least onecross-pin through said at least one cross-pin hole.

BRIEF DESCRIPTION OF THE DRAWINGS

The above and other objects and features of the present invention willbe more fully discussed in, or rendered obvious by, the followingdetailed description of the preferred embodiments of the invention,which is to be considered together with the accompanying drawingswherein like numbers refer to like parts, and further wherein:

FIG. 1-13 are various views of one form of a cross-pin guide assemblyfor use in cross-pinning a graft in a tibial tunnel, illustrative of onepreferred embodiment of the present invention;

FIG. 14 is a diagrammatical view of a human knee joint and illustrativeof a step in a method in which the cross-pin guide assembly of FIGS.1-13 is used;

FIGS. 15-34 are diagrammatical views illustrating a ligamentreconstruction procedure in which the cross-pin guide of FIGS. 1-13 isused;

FIGS. 35-38 are various views of another form of a cross-pin guideassembly for use in cross-pinning a graft in a tibial tunnel,illustrative of another preferred embodiment of the present invention;

FIG. 39 is a schematic view of a kit of bone tunnel guide rods for usewith a third embodiment of the present invention;

FIG. 40 is a schematic view showing one of the bone tunnel guide rods ofFIG. 39 with an associated cross-pin guide assembly;

FIG. 41 is a schematic side view of a harvested tendon;

FIG. 42 is a schematic side view of a graft ligament created from theharvested tendon shown in FIG. 41;

FIG. 43 is a schematic side view of an alternative form of graftligament created from the harvested tendon shown in FIG. 41;

FIG. 44 is a schematic top view of the graft ligament shown in FIG. 43;

FIG. 45 is a schematic top view of an alternative form of graft ligamentcreated from two of the harvested tendons shown in FIG. 41;

FIG. 46 is a schematic side view of an alternative form of graftligament created from the harvested tendon shown in FIG. 41;

FIG. 47 is a schematic top view of the graft ligament shown in FIG. 46;

FIG. 48 is a schematic side view of an alternative form of graftligament created from the harvested tendon shown in FIG. 41 and a pieceof bone.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

Looking first at FIGS. 1-10, there is shown a cross-pin guide assembly 5for placement of at least one cross-pin (not shown in FIGS. 1-10) in abone tunnel, such as the tibial tunnel of a knee joint. Cross-pin guideassembly 5 comprises an L-shaped member 10 having a base portion 15 andan arm portion 20. The arm portion 20 extends transversely to, andpreferably is normal to, base portion 15.

Cross-pin guide assembly 5 further comprises a bone tunnel guide rod 25which, adjacent to a first end 30 thereof, forms a diametrical,longitudinally-elongated passageway 35, and which, at a second end 40thereof, is releasably connectable to base portion 15 of L-shaped member10. In a preferred embodiment, bone tunnel guide rod 25 is cannulatedalong its axis 65 (see FIGS. 1-10) for placement on a guidewire (notshown in FIGS. 1-10). Bone tunnel guide rod 25 may be retained in a bore45 formed in base portion 15 by a set screw 50. In an alternativeembodiment, bone tunnel guide rod 25 may be fixedly connected to baseportion 15.

Still looking at FIGS. 1-10, a movable element 55 is positioned on bonetunnel guide rod 25 between first end 30 and second end 40. Movableelement 55 may be moved about on guide rod 25 so that the distance ofmovable element 55 from first end 30 may be selectively adjusted.Movable element 55 may also be secured to guide rod 25 at any of theselongitudinal positions. In one preferred form of the invention, movableelement 55 is movably secured to guide rod 25 using a ratchet systemsuch as that shown in FIGS. 1-10.

The present invention may be practiced with cross-pins of any type, andis independent of the type of cross-pins used in a surgical procedure.Preferably, cross-pins of an absorbable nature are used in a givensurgical procedure. Accordingly, the ACL reconstruction will hereinafterbe discussed in the context of using absorbable cross-pins, and in thecontext of using preferred apparatus for deploying such absorbablecross-pins.

More particularly, in a preferred embodiment using absorbable cross-pins255, 260 (FIG. 34), a trocar sleeve guide member 58 (FIGS. 1-10) isremovably connectable to arm portion 20 of L-shaped member 10. Trocarsleeve guide member 58 is provided with bores 60 extending therethrough.Bores 60 intersect the longitudinal axis 65 of the bone tunnel guide rod25. As such, at least one cross-pin is ultimately positioned in thetibia so as to pass through the tibial tunnel. More preferably, bores 60are configured to intersect the longitudinal axis 65 of bone tunnelguide rod 25 just below the patient's tibial plateau. In this way, theat least one cross-pin will be deployed in the cortical portion of thetibia, adjacent to the tibial plateau, and at the region of greatestbone strength. A set screw 70 may be used to releasably retain trocarsleeve guide member 58 in position on arm portion 20. Alternatively, orin addition, arm portion 20 may be provided with stop means (not shown)for limiting movement of the trocar sleeve guide member 58 along armportion 20. Trocar sleeve guide member 58 is preferably formed in twohalves releasably held together by a set screw 75, whereby trocar sleeveguide member 58 can be detached from first and second trocar sleeves 80,85 passing through bores 60, as will hereinafter be discussed.

First and second trocar sleeves 80, 85 (FIGS. 1-10 and 11-13) areslidably received by bores 60 (FIG. 1) such that sleeves 80, 85 areaxially and rotatably movable in bores 60. Trocar sleeves 80, 85 areeach provided with a collar portion 90 having a diagonally-extendingslot 95 formed therein. Cross-pin guide assembly 5 also preferablyincludes one or more trocars 100 (FIGS. 1-10 and 11-13) for dispositionin sleeves 80, 85. Each trocar 100 is provided with a sharp end 105 forpenetration of bone. A transversely-extending pin 110 is provided near,but spaced from, the opposite end of trocar 100. Pin 110 is fixed inplace and is received by the slot 95 of trocar sleeves 80, 85 such thataxial (in a distal direction) and rotational movement of trocar 100causes similar movement of sleeves 80, 85.

First and second absorbable rods 255, 260 (see FIG. 34), or rods ofother types of known materials, are slidable through sleeves 80, 85, aswill be further described hereinbelow.

In another preferred embodiment, guide member 58 is configured for thedirect placement of cross-pins, without the use of trocar sleeves 80, 85and trocars 100. In this case, the cross-pins are inserted through, andguided by, each of bores 60 in guide member 58.

Referring now to FIG. 14, there is shown a human knee joint 115including a femur 120 and a tibia 125. An appropriate femoral tunnel 130and an appropriate tibial tunnel 135 are provided, as by means andmethods well known in the art. A guidewire 140 extends through thetunnels 130, 135 as shown.

Now looking at FIG. 15, a femoral cross-pinning rack assembly 145, oranother similar system, is provided to position cross-pins 255, 260(FIG. 30) across femoral tunnel 130. Using rack assembly 145, acannulated sleeve 155 is loaded on guidewire 140, passed through tibialtunnel 135 and up into femoral tunnel 130 until the cannulated sleeve'shead portion 160 (FIG. 15) engages in an annular shoulder 165 in femoraltunnel 130. Guidewire 140 extends through a bore 170 (FIG. 15) formed ina base portion 175 of L-shaped member 180. The cannulated sleeve's headportion 160 is preferably sized so as to form a snug fit in femoraltunnel 130. Cannulated sleeve 155 may be positioned in the bone tunnels130, 135 and then connected to L-shaped member 180 or, more preferably,cannulated sleeve 155 may be first connected to L-shaped member 180 andthen positioned in femoral tunnel 130 and tibial tunnel 135. Trocarsleeve guide member 185 (FIG. 15), if not already positioned on an armportion 190, is then fixed to arm portion 190, as by a set screw (notshown).

Now looking at FIG. 16, first trocar sleeve 200 is then inserted in abore 205 of guide member 185 (FIG. 16), and trocar 210 is extendedthrough sleeve 200 until pin 215 of trocar 210 is nestled in slot 220 ofsleeve 200, with the trocar's sharp end 225 extending beyond the distalend of sleeve 200. Alternatively, trocar 210 may be mounted in firsttrocar sleeve 200 before the first trocar sleeve 200 is mounted in bore205. In any case, the combination of trocar sleeve 200 and trocar 210 isthen drilled, as a unit, into femur 120 toward, but stopped short of,the enlarged head portion 160 of cannulated sleeve 155 (FIG. 16).

Trocar 210 may then be withdrawn from first trocar sleeve 200 and placedin a second trocar sleeve 230 (FIG. 17). Alternatively, a second trocar210 may be provided for second trocar sleeve 230. In either case, thecombination of trocar sleeve 230 and trocar 210 is then drilled, as aunit, into femur 120 toward, but again stopped short of, head portion160 of cannulated sleeve 155 (FIG. 17). The rack's L-shaped member 180may then be removed from the surgical site (FIG. 18). This may beaccomplished by first loosening a set screw (not shown) to separatetrocar sleeve guide member 185 into its two halves, whereby trocarsleeves 200, 230 will be freed from guide member 185, and then slidingcannulated sleeve 155 downward along guidewire 140 until the cannulatedsleeve emerges from bone tunnels 130, 135. This procedure will leavetrocar sleeves 200, 230 lodged in femur 120 (FIG. 18).

Referring now to FIG. 19, the bone tunnel guide rod 25 (FIGS. 1-10) isfed over guidewire 140 and up into tibial tunnel 135 until the guiderod's first end 30 is aligned with tibial plateau 235. An arthroscope240 may be used to determine when the guide rod's first end 30 isaligned with tibial plateau 235.

Referring now to FIG. 20, movable element 55 (FIGS. 1-10) is then movedalong guide rod 25 toward the guide rod's first end 30 and tibia 125.When movable element 55 is positioned against tibia 125 (and the guiderod's first end 30 is positioned adjacent tibial plateau 235), movableelement 55 is locked in position such that guide rod 25 cannot travelfurther into tibial tunnel 135. In this configuration, guide assembly 5may be stabilized against tibia 125 by applying a distally-directedforce to guide rod 25, with movable element 55 maintaining the positionof the guide rod relative to tibia 125.

Now looking at FIG. 21, bone tunnel guide rod 25 is shown connected toL-shaped member 10 and positioned in tibial tunnel 135. In oneembodiment, bone tunnel guide rod 25 may be first connected to L-shapedmember 10 and then positioned in tibial tunnel 135. Alternatively, in apreferred embodiment, bone tunnel guide rod 25 is first positioned intibia tunnel 135 and then connected to L-shaped member 10. In eithercase, movable element 55 properly locates bone tunnel guide rod 25relative to tibia 125 so that the guide rod's first end 30 is alignedwith tibial plateau 235. Trocar sleeve guide member 58 (FIGS. 1-10), ifnot already positioned on arm portion 20, is then fixed to arm portion20, such as by set screw 50 (FIGS. 1-10). Guide assembly 5 has ageometry such that when first end 30 of bone tunnel guide rod 25 ispositioned in tibial tunnel 135, and movable element 55 is in engagementwith the front surface of tibia 125, the cross-pins 255, 260 (FIG. 34)will be directed with a desired orientation within the tibial bone and,more preferably, through the strong cortical bone located just below thetibial plateau 235 (FIG. 34).

Now referring to FIG. 22, first trocar sleeve 80 is then inserted inbore 60 of guide member 58, and trocar 100 is extended through sleeve80, with the trocar's sharp end 105 extending beyond the distal end ofsleeve 80. Alternatively, trocar 100 may be mounted in first trocarsleeve 80 before first trocar sleeve 80 is mounted in the guide member'sbore 60. In either case, the combination of trocar sleeve 80 and trocar100 is then drilled, as a unit, into tibia 125 toward, but stopped shortof, the guide rod's passage 35 (FIG. 22).

Trocar 100 may then be withdrawn from first trocar sleeve 80 and placedin second trocar sleeve 85. Alternatively a second trocar 100 may beprovided for second trocar sleeve 85. In either case, the combination oftrocar sleeve 85 and trocar 100 is then drilled (FIG. 23) as a unit intotibia 125 toward, but stopped short of, the guide rod (FIG. 24).

The guide assembly's L-shaped member 10 may then be removed from thesurgical site. This may be accomplished by first loosening set screw 75(FIGS. 1-10) so as to separate trocar sleeve guide member 58 into itstwo halves, whereby trocar sleeves 80, 85 will be freed from guidemember 58, and then sliding bone tunnel guide rod 25 downward alongguidewire 140 until the guide rod 25 emerges from tibial bone tunnel135. This procedure will leave trocar sleeves 80, 85 lodged in tibia 125(FIG. 25).

Significantly, due to the geometry of guide assembly 5, trocar sleeves80, 85 (and hence cross-pins 255, 260) will be directed into the strongcortical bone located just beneath tibial plateau 235.

Guidewire 140 is then used to pull a suture 245, which is attached to agraft ligament 250 (including, but not limited to, soft tissue graftsand bone block grafts) up through tibial tunnel 135 and into femoraltunnel 130, until graft ligament 250 engages the annular shoulder 165 infemoral tunnel 130 (FIG. 26). Guidewire 140 may be provided with aneyelet (not shown) adjacent to its proximal end so as to facilitate thisprocedure. Graft ligament 250 can then be held in this position bymaintaining tension on the portion of suture 245 emerging from the topof femur 120.

Trocar 210 may then be removed from second trocar sleeve 230, placed infirst trocar sleeve 200, and then sleeve 200 and trocar 210 drilledthrough the distal end of graft ligament 250, as shown in FIG. 27.Trocar 210 may then be removed from sleeve 200, placed in second sleeve230, and second sleeve 230 and trocar 210 drilled through the distal endof graft ligament 250, as also shown in FIG. 27. The trocar 210 (ortrocars 210 if more than one trocar is used) may then be withdrawn fromsleeves 200, 230 (FIG. 28). A first absorbable rod 255 (FIG. 29) is thendeployed, by sliding rod 255 through trocar sleeve 200, into a positionextending through ligament 250. Sleeve 200 may then be withdrawn fromligament 250 and femur 120, leaving first absorbable rod 255 in place infemur 120 and extending through ligament 250. Similarly, secondabsorbable rod 260 may be slid into place through sleeve 230. Sleeve 230is then removed, leaving second absorbable rod 260, along with firstabsorbable rod 255, extending through ligament 250 so as to lockligament 250 in place in femoral tunnel 130, as shown in FIG. 29.

Looking next at FIG. 30, graft ligament 250 is then held in position bymaintaining tension on the proximal portion of ligament 250 emergingfrom the bottom of tibia 125.

Next, graft ligament 250 is attached to tibia 125. More particularly,first trocar sleeve 80 and a trocar 100 are drilled through ligament250, as shown in FIG. 31. Trocar 100 may then be removed from firstsleeve 80, placed in second sleeve 85, and second sleeve 85 and trocar100 drilled through ligament 250, as shown in FIG. 32. Alternatively, asecond trocar 100 may be provided for use with second sleeve 85. Ineither case, after trocar sleeves 80 and 85 have been set, the trocar100 (or trocars 100, if more than one trocar is used) may then bewithdrawn from sleeves 80, 85 (FIG. 33). A first absorbable rod 255 isthen inserted, by sliding rod 255 through trocar sleeve 80, into aposition extending through ligament 250. Sleeve 80 may then be withdrawnfrom ligament 250 and tibia 125, leaving first absorbable rod 255 inplace in tibia 125 and extending through ligament 250. Similarly, asecond absorbable rod 260 is then slid into place through sleeve 85.Sleeve 85 is then removed, leaving second absorbable rod 260, along withfirst absorbable rod 255, extending through ligament 250 so as to lockligament 250 into place in tibial tunnel 135, as shown in FIG. 34.

Now referring to FIGS. 35-38, there is shown a bone tunnel referenceguide 265 for placement of at least one cross-pin (not shown in FIGS.35-38) in a bone tunnel such as the tibial tunnel of a knee joint. Bonetunnel reference guide 265 may be used in procedures to fix graftligaments (including both soft tissue grafts and bone block grafts) inbone tunnels. Bone tunnel reference guide 265 comprises an L-shapedmember 270 having a base portion 275 and an arm portion 280. The armportion 280 extends transversely to, and preferably is normal to, baseportion 275.

Bone tunnel reference guide 265 further comprises a bone tunnel guiderod 285 having a first end 290 and a second end 295. Bone tunnel guiderod 285 includes a gradiated index 300 between first end 290 and secondend 295. Bone tunnel guide rod 285 includes a diametrically-extending,longitudinally-elongated passageway 305 intermediate its length and, atsecond end 295, is connected to base portion 275 of L-shaped member 270.In a preferred embodiment, bone tunnel guide rod 285 is cannulated at306 (FIG. 35) for placement on a guidewire (not shown in FIG. 35). Bonetunnel guide rod 285 may be retained in a bore 315 formed in baseportion 275 by a pin 320.

Still looking at FIGS. 35-38, a scale 325 is provided on arm portion 280of L-shaped member 270. Scale 325 is coordinated with gradiated index300 on bone tunnel guide rod 285 as will hereinafter be discussed.

The present invention may be practiced with cross-pins of any type, andis independent of the type of cross-pins used in a surgical procedure.Preferably, cross-pins of an absorbable nature are used in a givensurgical procedure. Accordingly, the ACL reconstruction will hereinafterbe discussed in the context of using absorbable pins, and in the contextof using preferred apparatus for deploying such absorbable pins.

More particularly, in a preferred embodiment using absorbablecross-pins, a trocar sleeve guide member 330 is removably connectableto, and selectably adjustable along, scale 325 of arm portion 280 ofL-shaped member 270. Trocar sleeve guide member 330 is provided withbores 335 extending therethrough. Bores 335 extend through alongitudinal axis 340 of bone tunnel guide rod 285. As such, at leastone cross-pin is ultimately positioned in the tibia so as to passthrough the tibial tunnel. More preferably, bores 335 are configured tointersect the longitudinal axis 340 of bone tunnel guide 285 just belowthe patient's tibial plateau. In this way, the at least one cross-pinwill be deployed in the cortical portion of the tibia, adjacent to andjust below the tibial plateau, and at the region of greatest bonestrength. A set screw 345 may be used to releasably retain trocar sleeveguide member 330 in position along scale 325 of arm portion 280. Trocarsleeve guide member 330 is preferably formed in two halves releasablyheld together by a set screw 350, whereby trocar sleeve guide member 330can be detached from first and second trocar sleeves 355, 360 passingthrough bores 335, as will hereinafter be discussed.

In another preferred embodiment, trocar sleeve guide member 330 isconfigured for direct placement of cross-pins, without the use of trocarsleeves 355, 360. In this case, cross-pins are inserted through, andguided by each of bores 335 in guide member 330.

Bone tunnel reference guide 265 is preferably used as follows. First,femoral tunnel 130 and tibial tunnel 135 (FIG. 14) are formed. Then thereference guide's guide rod 285 (FIGS. 35-38) is passed up tibial tunnel135 and femoral tunnel 130 until the distal end 290 of guide rod 285 isin engagement with the distal end 165 of femoral tunnel 130 (FIG. 14).As this occurs, the reference guide's L-shaped member 270 will supporttrocar sleeve guide member 30 outboard of the patient's femur.Stabilization of the bone tunnel reference guide 265 is provided byapplying a distally-directed force to guide rod 285, which is inengagement with the distal end 165 of femoral tunnel 130. Thisstabilization allows accurate placement of the cross-pins. Then anarthroscope is used to read the gradiated index 300 at the point atwhich guide rod 285 crosses the tibial plateau. Trocar sleeve guidemember 330 is then set at a corresponding location along its own scale325. In this respect it will be appreciated that gradiated index 300 iscoordinated with scale 325 so that the axes of bores 335 (FIG. 35), andhence the cross-pins, will pass through the tibia at a desired position,such as through the tibia's cortical bone just below the tibial plateau.

Next, drill sleeves 355, 360 are used to set trocars 365, 370 into thetibia. Trocar sleeve guide member 330 is then separated into its twohalves so as to free drill sleeves 355, 360 from reference guide 265,and the reference guide 265 is removed from the surgical site, e.g., bywithdrawing it proximally off the guidewire. Then the graft ligament ispulled up into femoral tunnel 130 and tibial tunnel 135, the distal endof the graft ligament is made fast in femoral tunnel 130, and then drillsleeves 355, 360 are used to set absorbable cross-pins through theproximal end of the graft ligament, whereby to cross-pin the ligament tothe tibia.

Now looking at FIG. 39, there is shown a kit 300 of bone tunnel guiderods 305 for use with a cross-pin guide assembly such as the cross-pinguide assembly 308 shown in FIG. 40. In one preferred form of theinvention, cross-pin guide assembly 308 is similar to the cross-pinguide assembly 5 shown in FIGS. 1-10, except that bone tunnel guide rod25 of cross-pin guide assembly 5 is replaced with one of the bone tunnelguide rods 305 shown in FIG. 39.

Each of the bone tunnel guide rods 305 includes a proximal end 310 and adistal end 315. As insertion limiting means 320, for limiting insertioninto a bone tunnel, is located between proximal end 310 and distal end315. Preferably insertion limiting means 320 comprises an annularshoulder formed intermediate the distal end 321 and the proximal end 322of a given bone tunnel guide rod 305.

Insertion limiting means 320 are located at a given distance 325 fromthe distal end 321 of bone tunnel guide rods 305. Each kit 300 includesat least two bone tunnel guide rods, with the given distance 325 of eachof the tunnel guide rods being different from one another. As such,selection is made from kit 300 by inserting at least one of the bonetunnel guide rods 305 into a bone tunnel and selecting the one of thebone tunnel guide rods 305 that has its distal end 321 aligned with thepatient's tibial plateau when insertion limiting means 320 are inengagement with the front side of the patient's tibia. As a result ofthis construction, when that selected bone tunnel guide rod 305 isloaded in cross-pin guide assembly 308, bores 60 (FIG. 40), and hencethe cross-pins, will be aimed at the thick cortical bone directlybeneath the tibial plateau, whereby to enable secure and reliable tibialcross-pinning.

It is to be understood that the present invention is by no means limitedto the specific applications thereof as herein disclosed and/or shown inthe drawings. For example, for illustrative purposes, the inventivemethod and apparatus are described herein and illustrated with referenceto the human knee joint. It is anticipated that the method and apparatusdescribed herein will be particularly beneficial with respect to suchoperations. However, it will also be appreciated by those skilled in theart that the method and apparatus described herein will find utilitywith respect to mammals generally, and with respect to other bones as,for example, in shoulder joints or the like.

Furthermore, trocars 100 and 210 are disclosed herein as being in theform of a hard rod with a sharp tip for penetrating bone. Thus, forexample, trocars 100 and 210 might comprise guidewires or K-wires with apyramidal front point. Alternatively, however, the invention might alsobe practiced with trocars 100 and 210 comprising a twist drill, a spadedrill and/or some other sort of drill.

Also it is contemplated that trocars 100 and/or 210 might be used withtheir associated guide member 58, rack assembly 145, reference guide265, guide assembly 308 and/or apparatus 400 to set absorbable rods 255,260, but without their associated sleeves 80, 85, and 200, 230,respectively. In this case, at least one trocar would always remainpositioned in graft ligament 250 until at least one absorbable rod 255,260 was positioned in the bone block.

If desired, it is also possible to practice the present invention usingjust one sleeve 80 and one trocar 100, or just one sleeve 85 and onetrocar 100, or just one sleeve 200 and one trocar 210, or without usingsleeves and/or trocars at all.

As noted above, the ACL reconstruction may be effected using a varietyof graft ligaments. More particularly, the graft ligament may comprisetissue harvested from the body, or it may comprise material notharvested from the body. In the former case, it is common for the graftligament to comprise a bone block with attached tendon (e.g., a patellatendon graft) or a tendon alone (e.g., the hamstring tendon).

In the case where the graft ligament comprises a tendon without anattached bone block, the method of harvesting the tendon frequentlyresults in the tendon having an uneven width at various points along itslength. In particular, in many cases, the harvested tendon will have athicker midsection portion and narrower end portions. For example, FIG.41 illustrates a harvested tendon 400 having first and second endportions 405 and 410, respectively, and a midsection portion 415.Harvested tendon 400 includes varying widths 420, 425 at first andsecond end portions 405 and 410, and at midsection portion 415,respectively. This can present problems in use, particularly inasmuch asit is common to “double up” the harvested tendon 400 (see FIG. 42), andthis can have the effect of amplifying variations in graft width.

More particularly, and looking now at FIG. 42, in a prior artconstruction, a graft ligament 430 is shown as formed from harvestedtendon 400 with a single fold. A graft ligament first end portion 435 isformed with harvested tendon midsection portion 415 folded upon andsutured to itself. A second end portion 440 of graft ligament 430 isformed with harvested tendon first and second end portions 405, 410sutured to one another. In this prior art configuration, single-foldedgraft ligament 430 is formed with first and second end portion 435, 440having differing thicknesses to one another. These differing thicknessesare a result of the relatively thin harvested tendon first and secondend portions 405, 410 being sutured to one another, and the relativelythick harvested midsection portion 415 being sutured to itself. Suchdiffering thicknesses of sutured tendon 430 may be detrimental for useas a graft ligament.

Referring now to FIGS. 43 and 44, in a preferred embodiment of thepresent invention, a graft ligament 445 is shown as formed fromharvested tendon 400 with a double fold (see FIG. 41). A first endportion 450 of double-folded graft ligament 445 is formed with harvesttendon first end portion 405 sutured to a first end 455 of harvestedtendon midsection portion 415 adjacent thereto. A second end portion 460of double-folded graft ligament 445 is formed with harvested tendonsecond end portion 410 sutured to a second length 465 of harvestedtendon midsection portion 415 adjacent thereto. In this preferredembodiment of the present invention, double-folded graft ligament 445 isformed with first and second lengths 455, 465 of harvested tendon 400being different lengths from one another. In another preferredembodiment of the invention (not shown), first and second lengths 455,465 may be similar, or equal to, one another. Double-folded graftligament 445 is formed such that first and second end portions 450, 460have substantially similar thicknesses to one another. Thesesubstantially similar thicknesses are a result of (1) the relativelythin first end portion 405 of harvested tendon 400 being sutured to therelatively thick midsection portion 415 of the harvested tendon 400 soas to form first end portion 450 of double-folded graft ligament 445,and (2) the relatively thin second end portion 410 being sutured to therelatively thick midsection portion 415 of harvested tendon 400 to formsecond end portion 460 of double-folded graft ligament 445.Double-folded graft ligament 445, with its relatively uniform thickness,may be beneficial for use within a bone tunnel.

Looking now at FIG. 45, in another preferred embodiment of the presentinvention, a graft ligament 470 is shown formed from multiple graftligaments 445 sutured to one another. Specifically, in this preferredembodiment of the present invention, two double folded graft tendons 445are sutured to one another. Each set of the multiple tendon graftligaments 445 may have first and second end portion 405, 410 inalignment with one another (see FIG. 45). Alternatively, the first andsecond end portions 405, 410 may be in a staggered configuration fromone another (not shown).

Referring now to FIGS. 46 and 47, in a preferred embodiment of thepresent invention, a graft ligament 475 is shown formed by harvestedtendon 400 having multiple folds. A first end portion 480 of multiplefolded graft ligament 475 is formed with first and second end portions405, 420 of harvested tendon 400 each folded upon itself and suturedtherebetween, respectively. A second end portion 485 of multiple-foldedgraft ligament 475 is formed with midsection portion 415 of harvestedtendon 400 folded upon, and sutured to, itself.

Still looking at FIGS. 46 and 47, multiple-folded graft ligament 475 maybe formed such that its first and second end portions 480, 485 havesubstantially similar thicknesses to one another. These substantiallysimilar thicknesses are a result of (1) the relatively thin first andsecond end portions 405, 410 of harvested tendon 400 each being foldedupon itself and sutured therebetween, and then being sutured to oneanother to form first end portion 480 of multiple-folded graft ligament475, and (2) the relatively thick midsection 415 of harvested tendon 400being folded upon itself and sutured therebetween to form second endportion. Multiple folded graft ligament 475 with a relatively uniformthickness may be beneficial for use within a bone tunnel.

Referring now to FIG. 48, in a preferred embodiment of the presentinvention, a graft ligament 490 is shown formed with harvested tendon400 and a bone core 495. A first end portion 496 of bone core graftligament 490 is formed with harvested tendon midsection portion 415folded upon itself. A second end portion 497 of bone core graft ligament490 is formed with bone core 495 secured between end portions 405, 410.For example, end portions 405, 410 may be secure together so as tosecure bone core 495 therebetween. In an alternative example, endportions 405, 410 may each be individually secured to bone core 495 soas to hold bone core 495 therebetween. In addition, midsection 415 maybe sutured together where it is folded upon itself.

Still looking at FIG. 48, bone core graft ligament 490 is shown formedsuch that its first and second end portions 496 and 497 havesubstantially similar thicknesses to one another. These substantiallysimilar thicknesses are a result of (1) the relatively thick midsectionportion 415 of harvested tendon 400 being folded upon itself to formfirst end portion 496 of bone core graft ligament 490, and (2) therelatively thin first and second end portions 405, 410 of harvestedtendon 400 being secured together with the thickness of bone core 495therebetween to form second end portion 497 of bone core graft ligament490. Bone core graft ligament 490, with this relatively uniformthickness, may be beneficial for use within a bone tunnel and alsoallows bone core crosspinning therethrough.

Numerous further variations, alterations, modifications and otherderivations of the present invention will occur and/or become obvious tothose skilled in the art in view of the foregoing detailed descriptionof the preferred embodiments of the present invention. Accordingly, itis to be understood that the foregoing specification and the appendeddrawings are intended to be illustrative only, and not as limiting ofthe invention.

1-11. (canceled)
 12. A graft ligament having a first end and second end,said first end and said second end defining a first longitudinal axis,and said graft ligament having a substantially uniform cross-sectionalthickness along said first longitudinal axis between said first end andsaid second end, said graft ligament comprising: a tendon having a thirdend and a fourth end, said third end and said fourth end defining asecond longitudinal axis therebetween, said tendon having a non-uniformcross-sectional thickness along said second longitudinal axis betweensaid third end and said fourth end, and said tendon having a firstportion, a second portion, and a third portion along said secondlongitudinal axis between said third end and said fourth end; and asecuring material securing at least one section of said first portion,said second portion, and said third portion with another at least onesection of said first portion, said second portion, and said thirdportion so as to form said third end and said fourth end, respectively,and so as to form said graft ligament with a substantially uniformcross-sectional thickness along said first longitudinal axis betweensaid first end and second end wherein said tendon has said firstportion, said second portion, and said third portion in series from saidthird end to said fourth end, and further wherein said second portionhas a given mean cross-sectional thickness, and said first portion andsaid third portion each have a smaller mean cross-sectional thicknessthan said given mean cross-sectional thickness wherein said firstportion and said third portion are each folded against said secondportion and sutured thereto, respectively wherein said first portion andsaid third portion are each folded upon itself along a third givenlength and a fourth given length, respectively, and sutured thereto,said second portion is folded upon itself and sutured therebetween, andsaid first portion and said third portion are sutured to one another.13. A graft ligament according to claim 12 wherein said third givenlength and said fourth given length are equal to one another.
 14. Agraft ligament according to claim 12 wherein said first given length islonger than said third given length.
 15. A graft ligament having a firstend and second end, said first end and said second end defining a firstlongitudinal axis, and said graft ligament having a substantiallyuniform cross-sectional thickness along said first longitudinal axisbetween said first end and said second end, said graft ligamentcomprising: a tendon having a third end and a fourth end, said third endand said fourth end defining a second longitudinal axis therebetween,said tendon having a non-uniform cross-sectional thickness along saidsecond longitudinal axis between said third end and said fourth end, andsaid tendon having a first portion, a second portion, and a thirdportion along said second longitudinal axis between said third end andsaid fourth end; and a securing material securing at least one sectionof said first portion, said second portion, and said third portion withanother at least one section of said first portion, said second portion,and said third portion so as to form said third end and said fourth end,respectively, and so as to form said graft ligament with a substantiallyuniform cross-sectional thickness along said first longitudinal axisbetween said first end and second end wherein said tendon has said firstportion, said second portion, and said third portion in series from saidthird end to said fourth end, and further wherein said second portionhas a given mean cross-sectional thickness, and said first portion andsaid third portion each have a smaller mean cross-sectional thicknessthan said given mean cross-sectional thickness wherein said firstportion and said third portion are each folded against said secondportion and sutured thereto, respectively wherein said second portion isfolded against itself, a bone core is disposed between said firstportion and said third portion, and said first portion and said thirdportion are secured together with said bone core disposed therebetween.16. A graft ligament according to claim 15 wherein said folded secondportion, forming a first segment and second segment, is suturedtherebetween.
 17. A graft ligament according to claim 12 furthercomprising at least two of said tendons secured together to form saidgraft ligament. 18-22. (canceled)
 23. A method of making a graftligament having a first end and second end, said first end and saidsecond end defining first a longitudinal axis, and said graft ligamenthaving a substantially uniform cross-sectional thickness along saidfirst longitudinal axis between said first end and said second end, saidmethod of making said graft ligament comprising: providing a tendonhaving a third end and a fourth end, said third end and said fourth enddefining a second longitudinal axis therebetween, said tendon having anon-uniform cross-sectional thickness along said second longitudinalaxis between said third end and said fourth end, and said tendon havinga first portion, a second portion, and a third portion along said secondlongitudinal axis between said third end and said fourth end; andsecuring at least one section of said first portion, said secondportion, and said third portion to another at least one section of saidfirst portion, said second portion, and said third portion so as to formsaid third end and said fourth end, respectively, and so as to form saidgraft ligament having a substantially uniform cross-sectional thicknessalong said first longitudinal axis between said first end and secondend; wherein said first portion, said second portion, and said thirdportion are in series from said third end to said fourth end, andfurther wherein the step of securing at least one section of said firstportion, said second portion, and said third portion to said another atleast one section of said first portion, said second portion, and saidthird portion includes the steps of folding said first portion againstitself, folding said third portion against itself, suturing said foldedfirst portion, suturing said folded third portion, folding said secondportion against itself, and suturing said folded second portion.
 24. Amethod of making a graft ligament having a first end and second end,said first end and said second end defining first a longitudinal axis,and said graft ligament having a substantially uniform cross-sectionalthickness along said first longitudinal axis between said first end andsaid second end, said method of making said graft ligament comprising:providing a tendon having a third end and a fourth end, said third endand said fourth end defining a second longitudinal axis therebetween,said tendon having a non-uniform cross-sectional thickness along saidsecond longitudinal axis between said third end and said fourth end, andsaid tendon having a first portion, a second portion, and a thirdportion along said second longitudinal axis between said third end andsaid fourth end, and securing at least one section of said firstportion, said second portion, and said third portion to another at leastone section of said first portion, said second portion, and said thirdportion so as to form said third end and said fourth end, respectively,and so as to form said graft ligament having a substantially uniformcross-sectional thickness along said first longitudinal axis betweensaid first end and second end; wherein said first portion, said secondportion, and said third portion are in series from said third portion tosaid fourth end, and further wherein the step of securing at least onesection of said first portion, said second portion, and said thirdportion to said another at least one section of said first portion, saidsecond portion, and said third portion includes the steps of foldingsaid second portion against itself, positioning a bone core between saidfirst portion and said third portion, and securing said first portionand said third portion together with said bone core disposedtherebetween.
 25. A method of making a graft ligament according to claim24 further comprising the step of securing said folded second portion toitself.